The Efficacy and Safety of Insulin Degludec/Liraglutide Combination (IDegLira) in Patients With T… (NCT06408532) | Clinical Trial Compass
Not Yet RecruitingPhase 4
The Efficacy and Safety of Insulin Degludec/Liraglutide Combination (IDegLira) in Patients With Type 2 Diabetes
256 participantsStarted 2024-04-30
Plain-language summary
The study aims to evaluate the efficacy and safety of IDegLira in type 2 diabetes who have failed premixed insulin therapy. The study plans to enroll 256 participants with inadequate glycemic control despite twice-daily subcutaneous injections of premixed insulin and metformin. Participants will be randomly assigned to either the premixed insulin dose optimization group (control group) or IDegLira once daily group, and the difference in change in glycated hemoglobin levels from baseline to 16 weeks of treatment will be assessed between the two groups.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Diagnosed with type 2 diabetes for ≥3 months. Meets the diabetes diagnostic criteria established by the World Health Organization (WHO) in 1999.
* Age ≥18 years, regardless of gender.
* Body mass index ≥23.0 kg/m\^2.
* HbA1c ≥7.5% and ≤11.0% at screening.
* Concurrently taking metformin, with a metformin dose ≥1500 mg/day or the maximum tolerated dose (not less than 1000 mg/day), and may be combined with oral sodium-glucose cotransporter-2 inhibitors, thiazolidinediones, or alpha-glucosidase inhibitors. Combination oral medications must be at a stable dose for ≥8 weeks and continued during the study period.
* For 8 weeks prior to screening, has been on a stable, regular regimen of premixed human insulin (including premixed insulin analogs) administered subcutaneously twice daily, with a total daily insulin dose of 15-50 units, in addition to diet and exercise control.
* Has signed the informed consent form.
* Willing and able to self-monitor blood glucose (SMBG) and record the diary card on time.
* Fully understands the study purpose and can communicate well with the investigator, and can understand and comply with all requirements of this study.
Exclusion Criteria:
* Subjects who have previously tested positive for diabetes autoantibodies (including anti-glutamic acid decarboxylase antibodies, anti-islet cell antibodies, anti-insulin antibodies, anti-zinc transporter 8 antibodies, and anti-protein tyrosine phosphatase antibodies).
* Fasting C-peptide…
What they're measuring
1
Hemoglobin A1c (HbA1c)
Timeframe: From baseline to the end of the study (week 0-week 14 ± 7days).